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RhoVac’s reports positive and constructive response from the European Medicines Agency in the now completed Scientific Advice Procedure

On June 19, 2018, RhoVac AB ("RhoVac") reported that the company has received response from the European Medicines Agency (EMA) on the Scientific Advice Procedure (Press release, RhoVac, JUN 19, 2018, View Source [SID1234555934]). EMA has stated that there are no further preclinical studies needed to be conducted to support the development of the proposed Phase IIb trial and that there is a clear window for early prostate cancer treatment with RhoVac’s drug candidate RV001.

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In alignment with company’s original schedule, RhoVac initiated a Scientific Advice Procedure with EMA in March 2018, to discuss progression of company’s RV001 project into a clinical phase IIb development, and to ensure that RhoVac’s approach was in line with EMA’s guidelines and expectations. Following this, in May, RhoVac was invited to participate at the EMA’s Scientific Advice Working Party’s (SAWP) meeting in London to further discuss the project. Now RhoVac has received the response which was adopted by The Committee for Medicinal Products for Human Use (CHMP) at their meeting 28 – 31 May 2018. The response given by SAWP is based on the questions and supporting documentation RhoVac submitted at the initiation of the procedure.

In summary, EMA has agreed that no further pre-clinical studies are needed to support the proposed phase IIb clinical trial development. EMA has also agreed that the company’s approach in development of a quality specification for RV001 drug candidate was in compliance with relevant regulatory guidelines.

In the response relating to the proposed clinical trial, which targets the early stage of prostate cancer, immediately after radical prostatectomy, EMA agreed that there is a clear window to treat in this stage of the disease using RhoVac’s RV001 drug candidate. Finally, EMA provided valuable advice to further definition of the patient population and on inclusion criteria for the patients to be enrolled in the proposed clinical study.

Comments from RhoVac´s CEO, Anders Ljungqvist

-The Scientific Advice Procedure including the face to face meetings with relevant experts at EMA have been extremely valuable for RhoVac assuring us that we are now in a position to refine and progress our plans for our clinical phase IIb development. To our knowledge, there are no other drugs in development targeting this very early stage of disease progression in prostate cancer while relevant regulatory guidelines for adjuvant treatment in this stage are scarce. The comments and advice from EMA are therefore crucial for the further development of our drug candidate RV001.

Celyad doses first AML patient at final dose level in CYAD-01 THINK trial and treats first patient with second cycle of therapy

On June 19, 2018 Celyad reported that 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 (Press release, Celyad, JUN 19, 2018, View Source [SID1234532514]). "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.

10-Q – Quarterly report [Sections 13 or 15(d)]

Oncbiomune has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Oncbiomune, 2018, JUN 19, 2018, View Source [SID1234527391]).

MID-POINT OF PATIENT ENROLMENT REACHED IN AIPAC TRIAL

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]).

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.

Targovax granted EU Patent for mutant-RAS neoantigen platform 2nd generation product TG02

On June 19, 2018 Targovax ASA ("Targovax" or "the Company"; OSE: TRVX), is a clinical stage company focused on developing and commercializing immune activators to target hard to treat solid tumors, reported that the European Patent Office has granted European Patent no 3079715, A Peptide mixture (Press release, Targovax, JUN 19, 2018, View Source [SID1234527398]). The patent protects the composition of Targovax’s mutant-RAS specific neoantigen vaccine TG02, for stimulating the immune system of cancer patients with RAS mutated tumors.

Targovax’s proprietary mutant-RAS neoantigen vaccine platform is designed to treat patients with tumors harboring RAS mutations. Mutations in the RAS genes are a driving cause of cancer development and progression, and is linked to poor prognosis. By inducing an anti-mutant-RAS specific immune response, the TG products have the potential to delay disease progression and increase survival, with a favorable safety profile compared to chemotherapy and many other treatment options.

TG02 expands the coverage of RAS mutations beyond TG01, and is targeting all relevant RAS exon 2 oncogenic point mutations which are found in the vast majority of all RAS mutated cancers. Currently, TG02 is being tested in an exploratory Phase Ib clinical trial in patients with locally recurrent RAS-mutated colorectal cancer in combination with the checkpoint inhibitor KEYTRUDA (clinical study CT TG02-01). This study will provide important clinical data on the safety, immune activation and mechanism of action of TG02.

Jon Amund Eriksen, inventor of the TG technology and Co-founder of Targovax, said: "We are glad to see the European patent for TG02 being granted, further strengthening Targovax’s intellectual property portfolio covering the very important mutant-RAS trunk neoantigens. RAS is mutated in 20-30% of all cancers, and this 2nd generation product from the TG platform puts Targovax in a position to address an important unmet medical need, which could eventually benefit all RAS mutated cancer patients."