On June 20, 2018 Aminex Therapeutics, Inc., a clinical-stage drug development company focused on advancing a novel cancer immunotherapy, reported it received clearance from the Food and Drug Administration to initiate the first Phase 1 clinical trial of its immuno-oncology drug candidate AMXT 1501, a small molecule polyamine uptake inhibitor, and the approved drug DiFluoroMethylOrnithine (DFMO, eflornithine), a polyamine synthesis inhibitor (Press release, Aminex Therapeutics, JUN 20, 2018, View Source [SID1234527410]). This immunotherapy treatment will be evaluated in patients with a broad range of advanced solid tumor cancers.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The open label, multicenter, dose-escalation trial will evaluate the safety and tolerability of AMXT 1501 alone, and in combination with DFMO, in more than 50 patients with advanced solid tumors. The trial will include a dose-ranging stage followed by an expansion phase. Evaluation of pharmacokinetics, pharmacodynamics and clinical response rates will be assessed. The trial is listed on the NIH clinical trial registry www.clinicaltrials.gov (Identifier: NCT03536728). NEXT Oncology of San Antonio, Texas is the first of four clinical sites planned for this trial. The first cancer patient received an initial dose on June 12, 2018.

"Initiating this first trial of our unique immunotherapy approach represents a significant milestone for Aminex Therapeutics. We are extremely excited to begin clinical evaluation of this investigational therapy that has demonstrated significant promise in many preclinical studies involving multiple animal solid tumor cancer models," said Jim Skaggs, Chief Executive Officer and Chairman of the Board of Aminex Therapeutics. "The primary goal of this trial is to determine the safety and appropriate dosage of AMXT 1501 and DFMO in combination. Efficacy indications will also be assessed. We are also pleased to announce the closure of a $10 million series B financing to support our clinical development efforts."

Aminex Therapeutics’ immunotherapy approach combines the company’s oral, small molecule polyamine uptake inhibitor, AMXT 1501, with the off-patent polyamine synthesis inhibitor, DFMO, approved for African sleeping sickness. AMXT 1501 is designed to work in conjunction with DFMO to constrain the production and uptake of polyamines – molecules found in high concentrations in cancer cells and linked to immune system suppression. Reducing polyamines and, in turn, decreasing myeloid-derived suppressor cells in the tumor microenvironment, allows for activation of the immune system to attack solid tumors. In preclinical studies involving multiple cancer models, AMXT 1501 + DFMO has been shown to be especially effective against cancers driven by MYC and RAS, two major oncogenes known to promote the development of many types of solid tumor cancers.

Aminex Therapeutics, which is led by an experienced management team, board of directors and scientific advisory board, announced the strengthening of its leadership team with the earlier appointments of Roger Ulrich, Ph.D. to its Board of Directors and Stephen B. Baylin, M.D., as member of the Scientific Advisory Board and clinical advisor. Dr. Ulrich is a founder of Calistoga Pharmaceuticals and formerly with Acerta Pharma, Merck, Abbott Laboratories and The Upjohn Company. He currently serves as director for Acerta Pharma, Remedy Pharmaceuticals and is a Senior Advisor to Frazier Healthcare Partners. Dr. Baylin is Virginia and D.K. Ludwig Professor of Oncology and Medicine, Co-Director of the Cancer Biology Division and Associate Director for Research Programs of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

On June 20, 2018 SillaJen, Inc., (KOSDAQ:215600), a clinical-stage, biotherapeutics company focused on the development of oncolytic immunotherapy products for cancer, reported the first patient has been enrolled in REN026, the Phase 1b clinical trial of Pexa-Vec (pexastimogene devacirepvec) in combination with cemiplimab (REGN2810) for the treatment of renal cell cancer (RCC) (Press release, SillaJen, JUN 20, 2018, View Source [SID1234527430]). The first patient was enrolled in the United States, with expansion to sites in South Korea and Australia anticipated over the coming weeks.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

SillaJen is collaborating with Regeneron to evaluate Pexa-Vec, SillaJen’s lead clinical candidate, in combination with Regeneron’s cemiplimab, an anti-PD1 monoclonal antibody. The aim of the trial is to assess the safety and efficacy of the combination in patients with unresectable or metastatic renal cell carcinoma. The study will also investigate the immune modulating potential of Pexa-Vec given concurrently with checkpoint inhibitor therapy by evaluating multiple blood and tissue biomarkers.

"Given the initial activity seen with Pexa-Vec monotherapy and the potential of oncolytic viruses to enhance anti-tumor immunity, combining Pexa-Vec with cemiplimab is quite rational and has the promise to build upon the activity of checkpoint inhibitor therapy alone in RCC. This trial will not only assess the clinical activity of the two agents but allow us to assess in more depth the changes elicited in anti-tumor immunity following treatment by examining peripheral blood and tumor samples. This will give us proof of concept data that will help us expand this approach to other tumor types," stated James Burke, M.D., chief medical officer at SillaJen.

About Pexa-Vec and the SOLVE Platform
Pexa-Vec is the most advanced product candidate from SillaJen’s proprietary SOLVE (Selective Oncolytic Vaccinia Engineering) platform. The vaccinia strain backbone of Pexa-Vec has been used safely in millions of people as part of a worldwide vaccination program, and over 300 cancer patients have been treated with Pexa-Vec to date. Pexa-Vec was engineered to target common genetic defects in cancer cells by deleting their thymidine kinase (TK) gene, thus making Pexa-Vec dependent on the cellular TK expressed at persistently high levels in cancer cells. Pexa-Vec is also engineered to express granulocyte-macrophage colony stimulating factor (GM-CSF) protein. GM-CSF complements the cancer cell lysis of the product candidate, leading to a cascade of events resulting in tumor necrosis, tumor vasculature shutdown and sustained anti-tumoral immune attack. Pexa-Vec has been shown to be effective when delivered both intratumorally and systemically by intravenous administration. Pexastimogene devacirepvec (Pexa-Vec) is currently being evaluated in a worldwide Phase 3 clinical trial for advanced primary liver cancer, and more information can be found at: View Source

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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.

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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.

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."

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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.