Aradigm 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, Aradigm, 2018, MAR 23, 2018, View Source [SID1234524962]).

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On March 23, 2018 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that the European Union’s (EU) European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of a conditional marketing authorization for Rubraca as monotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum based chemotherapy, and who are unable to tolerate further platinum based chemotherapy (Press release, Clovis Oncology, MAR 23, 2018, View Source [SID1234525457]).

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The European Marketing Authorization application for the treatment indication was based on objective response rate and duration of response results from two multicenter, single-arm, open-label clinical trials, Study 10 and ARIEL2, in women with advanced BRCA mutant ovarian cancer who had progressed after two or more prior chemotherapies.

"The recommendation to approve Rubraca as monotherapy is welcome news, as once approved it will offer a new treatment option for women with advanced, recurrent ovarian cancer who have BRCA mutant platinum sensitive disease and are unsuitable for platinum based chemotherapy. In this analysis, we observed many women benefiting from extended progression-free survival with acceptable tolerability," said Dr. Rebecca Kristeleit, Clinical Senior Lecturer and Consultant Medical Oncologist, University College London/University College London Hospitals UK. "These are really important data demonstrating meaningful efficacy and a new non-chemotherapy treatment option for this group of patients who have already been exposed to a number of chemotherapy regimens."

Ovarian cancer is the sixth deadliest cancer amongst women in Europe, where more than 65,000 women are diagnosed annually.i Ovarian cancer is challenging to treat, and most women will relapse after surgery and chemotherapy. The 80 to 85 percent of women diagnosed in the later stages of the disease (III and IV) have particularly poor outcomes.ii Approximately one in four women with ovarian cancer have a germline or somatic BRCA mutation,iii and new treatment options are needed to treat unique patient populations.

"We are extremely pleased to have received a positive recommendation for approval for Rubraca in an ovarian cancer treatment indication, and we look forward to receiving the formal approval from the European Commission in second quarter 2018," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "This is great news for women living with this difficult disease who often have limited options available. In addition, this opinion from CHMP paves the way for the review of Rubraca in the ovarian cancer maintenance indication, based on the ARIEL3 data. We intend to file a variation to the Marketing Authorization (MA) in June, with a potential recommendation for approval in the broader maintenance indication by the end of 2018."

Pending approval for the treatment indication, Clovis plans to submit the variation to the MA based on data from the phase 3 ARIEL3 clinical trial, which found that rucaparib significantly improved progression-free survival in all ovarian cancer patient populations studied. ARIEL3 is a double-blind, placebo-controlled trial of rucaparib that enrolled 564 women with platinum-sensitive, high-grade ovarian, fallopian tube, or primary peritoneal cancer. The primary efficacy analysis evaluated three prospectively defined molecular sub-groups in a step-down manner: 1) BRCA mutant (BRCAmut+); 2) HRD positive (HRD+) inclusive of BRCA mutant; and finally, 3) the intent-to-treat population, or all patients treated in ARIEL3. The study achieved its primary endpoint of improved PFS by investigator review in each of three populations. The variation to the MA will be directed at the broader intent-to-treat or "all comers" population.

About Rubraca (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. Studies open for enrollment or under consideration include ovarian, prostate, breast, gastroesophageal, pancreatic, lung and bladder cancers. Clovis holds worldwide rights for Rubraca.

In the United States, Rubraca is approved on an accelerated basis as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer, who have been treated with two or more chemotherapies, and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. In December 2017, the U.S. Food and Drug Administration (FDA) accepted the Company’s supplemental New Drug Application (sNDA) for Rubraca for a second-line or later maintenance treatment indication in ovarian cancer based on the ARIEL3 data. The FDA granted Priority Review status to the application with a Prescription Drug User Fee Act (PDUFA) date of April 6, 2018.

Rubraca is an unlicensed medical product outside of the U.S.

On March 22, 2018 Caladrius Biosciences, Inc. (Nasdaq: CLBS) ("Caladrius" or the "Company"), a development-stage biopharmaceutical company with multiple technology platforms targeting autoimmune and select cardiovascular indications, reported that financial results for the three and twelve months ended December 31, 2017 and provides a business update (Press release, Caladrius Biosciences, MAR 22, 2018, View Source [SID1234524949]).

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Highlights of the 2017 fourth quarter and recent weeks include:

Completed enrollment in The Sanford Project: T-Rex Study;

Dosed first patient in Phase 2 clinical trial in Japan with Caladrius’ proprietary CD34 cell therapy (CLBS12) for the treatment of no-option critical limb ischemia ("CLI");

Acquired from Shire plc (LSE: SHP, Nasdaq: SHPG) an exclusive worldwide license to data and regulatory filings from a late stage CD34 cell therapy program for the treatment of chronic myocardial ischemia targeting refractory angina ("RfA"); and

Reported results from the predetermined interim analysis in The Sanford Project: T-Rex Study, which concluded the treatment to be well-tolerated and non-futile for therapeutic effect.

Management Commentary

"The past months have been especially productive as we made much progress advancing and expanding our clinical development pipeline," stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius.
"We were particularly pleased to acquire the late-stage asset from Shire’s CD34 cell therapy program for the treatment of refractory angina. In addition to adding a potentially late-stage product candidate that is complementary to our current pipeline in ischemic repair, this program represents a large potential commercial opportunity as refractory angina afflicts approximately one million people in the U.S. alone, with an incidence rate of 50,000 to 100,000 annually.1
"Our active clinical programs continue to progress well and we were delighted to complete enrollment in our landmark Phase 2 T-Rex study in children and adolescents with recent onset type 1 diabetes. We subsequently reported the conclusions of the independent statisticians for the predetermined interim analysis that the therapy continues to be well tolerated and was deemed non-futile as determined by pre-defined futility criteria for therapeutic effect. This analysis was triggered by 50% of the targeted total number of patients completing six months of follow-up. We look forward to completing and reporting the 12-month follow-up on all 110 patients in early 2019 as the complete data set will inform the next steps in our development plan.

1 Global Cardiology Science & Practice: April 30, 2015
"We believe that we have an exciting year ahead as we plan to advance a number of key clinical programs in cardiovascular indications such as CLI, coronary microvascular dysfunction and RfA and as we near the completion of the T-Rex study in type 1 diabetes. We continue to build on our recent accomplishments and hope to attain a number of value-creating inflection points throughout the balance of the year and beyond," Dr. Mazzo continued.

Fourth Quarter Financial Highlights

Note: Effective with the sale of PCT to Hitachi in the second quarter of 2017, all PCT-related activities and gain on sale results will be reported as discontinued operations. All remaining operations will be reported as continuing operations. In addition, all prior year comparative financial results will restate PCT operations as discontinued operations.
Research and development (R&D) expenses for the fourth quarter of 2017 of $4.7 million increased 45% compared with $3.2 million in the fourth quarter of 2016, as the Company focused its R&D efforts on the ongoing Phase 2 T-Rex Study and preparations for other pipeline programs, including the initiation of our CLI clinical program in Japan. Caladrius’ clinical development programs are supported, in part, by grants and collaborations.
General and administrative (G&A) expenses for the fourth quarter of 2017 increased 17% to $2.7 million, compared with $2.3 million in the fourth quarter of 2016.
The net loss from continuing operations for the fourth quarter of 2017 was $4.0 million, and included a non-cash tax benefit of $3.2 million, compared with $5.7 million for the comparable 2016 period. The non-cash tax benefit in 2017 is principally offset by non-cash tax expense reported in discontinued operations.
Income from discontinued operations for the fourth quarter of 2017 was $1.1 million, which represented a non-cash income tax adjustment on gain on the sale of PCT to Hitachi in the second quarter of 2017.
Net loss per share from continuing operations attributable to Caladrius common stockholders for the fourth quarter of 2017 was $0.40 per share compared to net loss per share of $0.69 for the same period in 2016.

2017 Financial Highlights

R&D expenses for 2017 decreased 5% to $15.8 million compared with $16.7 million for the 2016 year. G&A expenses decreased 8% to $11.8 million for 2017 compared with $12.8 million for the 2016 year. 2017 included $1.9 million of equity compensation expense related to the acceleration of employee equity stock and option award vesting triggered by the sale of the Company’s PCT subsidiary to Hitachi.
The net loss from continuing operations for the twelve months ended December 31, 2017 was $16.2 million, compared with the net loss from continuing operations of $31.3 million for the same period of
2016. The continuing operations net loss includes a non-cash tax benefit of $11.5 million, which is substantially offset by a non-cash tax expense reported in discontinued operations.
Income from discontinued operations during 2017 was $38.4 million, which includes a $41.2 million gain on the sale of PCT (net of $10.5 million taxes), compared with a loss from discontinued operations of
$2.1 million in the same period in 2016.

Net loss per share from continuing operations attributable to Caladrius common stockholders for the twelve months ended December 31, 2017 was $1.78 per share compared to a net loss per share of $4.74 for the same period in 2016.

Balance Sheet Highlights

As of December 31, 2017, Caladrius had cash, cash equivalents, restricted cash and marketable securities of $60.1 million compared with $7.1 million as of December 31, 2016. During 2017, the Company received gross proceeds of $79.4 million from the sale of PCT and $5.7 million in proceeds from stock issuance.
Based on existing programs and projections, the Company is confident its cash balances and additional grant funding, along with continued disciplined expense management, will allow it to fund its current business plan

beyond 2019.

Conference Call

Caladrius’ management will host a conference call for the investment community beginning today at 4:30 p.m. Eastern Time to review financial results, provide a Company update and answer questions.
Shareholders and other interested parties may participate in the conference call by dialing 866-595- 8403 (U.S.) or 706-758-9979 (international) and providing conference ID 8668599. The call will also be broadcast live on the Company’s website at www.caladrius.com/events.
For those unable to participate in the live conference call or webcast, a replay will be available beginning March 22, 2018 two hours after the close of the conference call. To access the replay, dial (855) 859- 2056 or (404) 537-3406. The replay passcode is: 8668599.

The webcast will be archived on the Company’s website for 90 days.

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).