On June 19, 2018 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company") reported that it has reached the mid-point in patient enrolment for its ongoing AIPAC Phase IIb clinical trial evaluating eftilagimod alpha ("efti" or "IMP321") in combination with paclitaxel in metastatic breast cancer (Press release, Immutep, JUN 19, 2018, View Source [SID1234527411]).

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A total of 113 patients have been enrolled in AIPAC, representing half of the 226 patients planned for the study. In 2018 clinical trial sites were opened in Germany, the UK, France and Hungary complementing the existing active sites in Belgium, Poland and the Netherlands, thereby leading to an acceleration of the monthly recruitment rate.

All clinical sites are now actively recruiting and treating patients as part of the randomised and controlled phase of the study. The primary clinical end-point of the study is Progression-Free Survival ("PFS"). Based on current projections, the AIPAC study is expected to be fully recruited with 226 patients by the end of calendar year 2018, with first PFS data expected in calendar year 2019.

Dr. Frederic Triebel, Immutep’s Chief Scientific Officer and Medical Officer, commented "We are very excited to have reached this important milestone. During the past 18 months, CDK4/6 inhibitors, such as Ibrance from Pfizer, have been gradually incorporated into the treatment regimen for metastatic breast cancer in various European countries. This has been done to reinforce and extend the hormonal therapy timeframe for patients before moving to the first line chemotherapy setting. As a onetime practice changing event it resulted in a temporary slowdown in the rate of recruitment for AIPAC, however this has now accelerated again especially as all European sites are now actively recruiting.

Possible changes in patient characteristics at the start of chemotherapy should not have an impact on the robustness of the AIPAC trial due to the double-blind randomization design. From a commercial perspective, the number of patients entering the first line chemotherapy setting should remain the same. There is a great deal of interest from patients, clinicians, and investors in the LAG-3 immune control mechanism and we are extremely pleased to be at the forefront of this rapidly emerging area of medicine with the clinical development of efti."

About the AIPAC clinical trial

The ongoing AIPAC (Active Immunotherapy PAClitaxel) Phase IIb clinical trial is a European multi-centre, randomised, double-blind, placebo-controlled study evaluating eftilagimod alpha ("efti" or "IMP321") in combination with paclitaxel in metastatic breast cancer (clinicaltrials.gov identifier NCT 02614833). The study consists of two parts: a safety run-in phase (15 patients) and a randomised and controlled phase (226 patients).

As announced previously, in the safety run-in phase of the study, the overall response rate ("ORR") in patients to the combination of paclitaxel and efti was 47%, and the disease control rate ("DCR") was 87%. It was also noted that two of the responses to the combination therapy occurred relatively late in the treatment (after ~6 months) and that the safety run-in phase reported a very encouraging safety profile.

On June 19, 2018 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell therapies, reported the first Acute Myeloid Leukemia (AML) patient was dosed with the first injections at the third and final dose level of CYAD-01 in the hematological arm of the Phase 1 THINK trial (Press release, Celyad, JUN 19, 2018, View Source [SID1234527393]).

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"The observed tolerability profile of CYAD-01 to date as a stand-alone administration, along with the signs of clinical activity observed in relapsed refractory AML, highlight its potential for further development for both hematological cancers and solid tumors," said Dr. Christian Homsy, CEO of Celyad. "We have started administering the third dose level of CYAD-01 in a relapsed refractory AML patient in the THINK trial with no toxicity observed after the first injections. We look forward to completing the dose-escalation segment of the study, and, potentially an expansion phase, and reporting on the interim results of the THINK trial later this year at scientific congresses. In addition, we are happy to report that the first patient to receive a second cycle of CYAD-01 has been injected earlier this month."

The open label Phase 1 THINK trial is being conducted in the US and in Europe. The dose-escalation segment, conducted in parallel in solid cancers and in hematologic cancer groups, includes three dose levels: 3×108, 1×109 and 3×109 CYAD-01 cells per dose. At each dose level, the patients receive three successive administrations, two weeks apart, of CYAD-01 at the specified dose.

We expect that a total of three AML patients will receive the third and final, highest dose level. To date in the THINK trial, CYAD-01 has already shown signs of clinical activity at lower doses in AML patients who have received one cycle of CYAD-01 treatment per protocol ranging from complete response to stable disease. Celyad previously reported the world’s first complete response by a CAR-T cell therapy, without pre-conditioning, in a patient with refractory and relapsed AML.

Based on the promising signs of activity observed to date, Celyad has started to evaluate if a second cycle of administration of CYAD-01 could improve or prolong the clinical responses. A first patient at the second dose level has successfully started his second cycle of treatment without any toxicity observed to date.

On June 19, 2018 Johnson & Johnson (NYSE: JNJ) reported it will host a conference call for investors at 8:30 a.m. (Eastern Time) on Tuesday, July 17, to review second-quarter results (Press release, Johnson & Johnson, JUN 19, 2018, View Source [SID1234527394]). Alex Gorsky, Chairman and Chief Executive Officer and Joseph J. Wolk, Executive Vice President, Chief Financial Officer will host the call.

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Investors and other interested parties can access the webcast/conference call in the following ways:

The webcast and presentation material are accessible at Johnson & Johnson’s website www.investor.jnj.com. A replay of the webcast will be available approximately three hours after the conference call concludes.
By telephone: for both "listen-only" participants and those financial analysts who wish to take part in the question-and-answer portion of the call, the telephone dial-in number in the U.S. is 877-869-3847. For participants outside the U.S., the dial-in number is 201-689-8261.
A replay of the conference call will be available until approximately 12:00 a.m. on July 25, 2018. The replay dial-in number for U.S. participants is 877-660-6853. For participants outside the U.S., the replay dial-in number is 201-612-7415. The replay conference ID number for all callers is 13680884.
The press release will be available at approximately 6:45 a.m. (Eastern Time) the morning of the conference call.

1stOncology’s ‘Commercial Interests at EHA (Free EHA Whitepaper) 2018‘ report highlights the landscape of commercial oncology drug development presenting abstracts at the 2018 European Hematology Association meeting. Below is some interesting headline points our analyst team picked from EHA (Free EHA Whitepaper) 2018, but if you would like to get the full picture, we invite you to 48 hours of free access to our European Hematology Association (EHA) (Free EHA Whitepaper) 2018 whitepaper report. Sign up here for your free access.

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Bispecific Cancer Antibodies at EHA (Free EHA Whitepaper) 2018 are Dominated by CD3 Targeting:

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On June 18, 2018 Stemline Therapeutics, Inc. (Nasdaq:STML), a clinical-stage biopharmaceutical company developing novel oncology therapeutics, reported that positive clinical data from ELZONRISTM (tagraxofusp; SL-401) trials were presented at the 23rdCongress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Stockholm, Sweden (Press release, Stemline Therapeutics, JUN 18, 2018, View Source [SID1234527374]).

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Results from the completed pivotal trial in blastic plasmacytoid dendritic cell neoplasm (BPDCN) were presented for the first time to a European audience. This oral presentation also included positive survival and safety updates. Updated results from ongoing clinical trials in patients with relapsed/refractory chronic myelomonocytic leukemia (CMML) or relapsed/refractory myelofibrosis (MF) were also presented and continue to indicate the potential of ELZONRIS in indications beyond BPDCN.

Copies of all three presentations are available on Stemline’s website (www.stemline.com) under the Scientific Presentations tab.

Highlights from the Pivotal Trial – BPDCN (ELZONRIS 5-day regimen, multicycle)

ELZONRIS demonstrated high response rates and high rate of stem cell transplant (SCT) in blastic plasmacytoid dendritic cell neoplasm (BPDCN)
° 90% overall response rate (ORR) in first-line (12 mg/kg; n=29); 69% ORR in relapsed/refractory (n=13)
• Majority of responses are complete responses
° 45% of patients treated with ELZONRIS in first-line (12 mg/kg) were bridged to stem cell transplant in remission (n=13)
No apparent cumulative adverse events, including in the bone marrow, over multiple cycles
Updated data: Median overall survival (OS) in first-line (12 mg/kg; n=29) not reached
Rolling BLA submission in BPDCN underway; on track for completion this quarter
Highlights from the CMML Phase 1/2 Trial (ELZONRIS 3-day regimen, multi-cycle)

ELZONRIS monotherapy demonstrated efficacy, including bone marrow complete responses and improvements in splenomegaly, with a manageable safety profile in patients with relapsed/refractory CMML, an area of high unmet medical need
° Patient enrollment and follow up continues
Manageable safety profile
° Most common treatment-related adverse events (TRAEs) included hypoalbuminemia (38%), thrombocytopenia (25%), and fatigue (25%). Most common TRAEs, grade 3+, include thrombocytopenia (25%) and nausea (6%)
2 bone marrow complete responses (BMCRs)
100% of evaluable patients had reduction in baseline splenomegaly (spleen response)
° 75% had reduction by ≥50%
° 60% with baseline spleen size ≥5cm had reduction by ≥50%
55% (6/11) evaluable patients with treatment duration 6+ months, including 8+ and 14+ months
Based on these encouraging results, registrational trial designs in patients with relapsed/refractory CMML are under evaluation
Highlights from the MF Phase 1/2 Trial (ELZONRIS 3-day regimen, multi-cycle)

ELZONRIS monotherapy demonstrated efficacy, namely improvements in splenomegaly, with a manageable safety profile, in patients with relapsed/refractory MF, an area of high unmet medical need
° Patient enrollment and follow up continues
Manageable safety profile
° Most common TRAEs include hypoalbuminemia and thrombocytopenia (each 27%), and alanine aminotransferase increased, anemia, dizziness, fatigue, headache and nausea (each 20%). Most common TRAEs, grade 3+, include anemia (20%) and thrombocytopenia and fatigue (each 7%)
50% of evaluable patients, with baseline spleen size ≥5cm, had reduction in baseline splenomegaly
° 33% had reduction by ≥33%
° 25% had reduction by ≥35%
67% (6/11) of patients with spleen response had treatment duration 8+ months, including 8+, 12+ and 14+ months (all 3 ongoing)
° 4 patients with baseline thrombocytopenia had treatment durations 8+ months, 3 ongoing
Initial Quality of Life assessments appear promising, and a full TSS (Total Symptom Score) analysis is ongoing
Based on these encouraging results, next steps for the program are being evaluated including single agent, combination, and registration-directed trials in patients with relapsed/refractory MF
Ivan Bergstein, M.D., Stemline’s CEO, commented, "We had another strong showing at a major oncology conference. Our ELZRONRIS pivotal data in BPDCN, which included positive updates around survival and safety, were showcased and very well-received at EHA (Free EHA Whitepaper). The completion of our rolling BLA submission remains on-track for this quarter, and we continue to aggressively advance our pre-launch activities." Dr. Bergstein continued, "Additionally, given the encouraging data we continue to see with ELZONRIS in patients with previously-treated CMML and previously-treated MF, we are actively evaluating registrational opportunities in these areas of unmet medical need."

About ELZONRISTM (tagraxofusp; SL-401)
ELZONRISTM (tagraxofusp; SL-401) is a novel targeted therapy directed to CD123, a cell surface receptor expressed on a range of malignancies. ELZONRIS has successfully completed a pivotal trial in blastic plasmacytoid dendritic cell neoplasm (BPDCN), an indication for which it was granted Breakthrough Therapy Designation (BTD). A rolling Biologics License Application (BLA) submission is underway. ELZONRIS is also being evaluated in additional clinical trials in other indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), and acute myeloid leukemia (AML).