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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]).

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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."

KAZIA RELEASES PRELIMINARY CANTRIXIL PHASE I DATA

On June 19, 2018 Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA), an Australian oncology-focused biotechnology company, reported an interim update to shareholders regarding its phase I clinical trial of Cantrixil (TRX-E-002-1) in relapsed or recurrent ovarian cancer (Press release, Kazia Therapeutics, JUN 19, 2018, View Source [SID1234527396]).

The phase I study of Cantrixil commenced in December 2016 at five centres in the United States and Australia. It is designed in two parts: a dose escalation component (Part A), which seeks to understand the safety profile of the drug and to determine the maximum tolerated dose (MTD), and a dose expansion cohort (Part B), which seeks to explore initial signals of efficacy. Part A is expected to enroll between 3 and 42 patients, and Part B is expected to enroll 12 patients. The study is registered with clinicaltrials.gov as NCT02903771.

At the present time, the study has enrolled 10 patients in Part A. In general, the drug has encountered few dose-limiting toxicities and, as a result, most dosing cohorts have only required enrolment of a single patient, in line with the trial protocol, which has allowed the study to progress with a number of patients towards the lower extent of the forecast range.

Of the 10 patients recruited to date, 2 were withdrawn from the study prior to receiving treatment, generally on grounds of disease progression, reflecting the severity of this patient population. 3 of 5 patients evaluable for efficacy thus far have achieved ‘stable disease’ (SD) per RECIST criteria after 2 cycles of Cantrixil monotherapy. One patient demonstrated a ‘partial response’ (PR) after receiving Cantrixil in combination with chemotherapy. 3 patients have so far completed the full twenty-four weeks of dosing allowed for in the protocol.

The Data Monitoring Committee has recommended that additional patients should be enrolled to more fully understand the safety profile and to definitively determine the maximum tolerated dose, and the company has therefore continued Part A accordingly. It is now expected that Part A will conclude in the third calendar quarter of 2018, at which time Part B will commence. The Company expects to provide comprehensive data once Part A is complete.

Kazia CEO, Dr James Garner, commented, "We are pleased with the progress of the study to date. Our understanding of both the safety and potential efficacy of Cantrixil will evolve as the study progresses further, and we look forward to sharing additional data as it is determined."

Johnson & Johnson to Host Investor Conference Call on Second-Quarter Results

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.

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.