On September 19, 2018 Abzena, plc (AIM: ABZA, Abzena’), the life sciences group providing services and technologies to enable the development and manufacture of biopharmaceutical products, reported that it has signed an antibody humanisation agreement with Tmunity Therapeutics (Tmunity), a clinical stage T cell therapy company and a leader in the development of new Chimeric Antigen Receptor T Cell (CAR-T) therapies for the treatment of solid and hematological cancers (Press release, Abzena, SEP 19, 2018, View Source [SID1234529491]).

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!

Under the agreement Abzena will humanize monoclonal antibodies using its Composite Human Antibody technology. This technology combines humanization and deimmunisation technologies to generate fully-humanized therapeutic antibodies devoid of CD4+ T cell epitopes.

Tmunity will use the humanised antibodies to develop CAR-T engineered products. CAR-T therapy is an innovative therapeutic form of personalised medicine in which a patient’s own T-cells are genetically modified to express an antigen recognizing CAR on the surface of the T cell. When the CAR-T encounters a cancer cell expressing the cognate antigen, the CAR-T is activated releasing cytokines that kill the cancer cell. CAR-T therapies have been successfully developed for the treatment of hematological cancers, a success that Tmunity is seeking to duplicate in solid tumors and other hematological malignancies.

The research and license agreement between Abzena and Tmunity also includes developability assessment to assess for any potential sequence liabilities that would affect quality of the product and EpiScreen, Abzena’s ex-vivo immunogenicity assessment platform.

Under the terms of the licence agreement Abzena will also be due milestone payments should products containing any of the humanized antibody sequences reach IND acceptance.

Campbell Bunce, SVP Scientific Operations of Abzena, said:

"We are delighted to be working with such an innovative organisation as Tmunity, to use our Composite Human Antibody platform to help design superior CARs for their CAR-T products. We believe that reducing the risk of immunogenicity of the receptor will contribute to a reduced risk profile for this exciting and potent treatment for cancer."

"Innovative use of our proprietary technology for an emerging and revolutionary drug platform like CAR-T, and utilisation of our protein engineering, immunology and bioanalytics expertise, is a great example of our ability to provide world-class support to our partners."

On September 19, 2018 Johnson & Johnson (NYSE: JNJ) reported that it will host a conference call for investors at 8:30 a.m. (Eastern Time) on Tuesday, October 16th, to review third-quarter results (Press release, Johnson & Johnson, SEP 19, 2018, View Source [SID1234529548]). Joseph J. Wolk, Executive Vice President, Chief Financial Officer and Christopher DelOrefice, Vice President, Investor Relations will host the call. The question and answer portion of the call will also include the following executives: Ashley McEvoy, Executive Vice President, Worldwide Chairman, Medical Devices; Jorge Mesquita, Executive Vice President, Worldwide Chairman, Consumer; and Jennifer Taubert, Executive Vice President, Worldwide Chairman, Pharmaceuticals.

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 October 24, 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 13683425.

The press release will be available at approximately 6:45 a.m. (Eastern Time) the morning of the conference call.

On September 19, 2018 MiNA Therapeutics, the pioneer in RNA activation therapeutics, reported an update from the ongoing Phase I study of small activating RNA (saRNA) candidate MTL-CEBPA in advanced liver cancer patients (Press release, MiNA Therapeutics, SEP 19, 2018, View Source [SID1234529492]). The Chief Investigator of the trial reported observations of tumour responses in three patients when administered approved liver cancer therapies subsequent to treatment with MTL-CEBPA. These responses corroborate emerging pre-clinical research on the potential for MTL-CEBPA to enhance the benefit of other cancer therapies and to modulate the tumour immune microenvironment. The update from the MiNA clinical trial was presented at the 12th Annual Conference of the International Liver Cancer Association in an oral presentation titled "First-in-Human, First-in-Class Phase I Study of MTL-CEBPA, a Small Activating RNA (saRNA) Targeting the Transcription Factor C/EBP-α in Patients with Advanced Liver Cancer" in the Novel Targets and Markers session held on Sunday, September 16, 2018.

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!

"Although these instances are anecdotal, complete responses of tumours are a rarity in primary liver cancer," said Dr. Debashis Sarker, the Chief Investigator of the study and Principal Investigator at the National Institute for Health Research Clinical Research Facility at Guy’s and St Thomas’ and King’s College London. "Observing two patients responding in this manner to approved cancer therapies subsequent to treatment with MTL-CEBPA is very encouraging. I am pleased that MiNA is seeking to modify its ongoing trial to include investigations on the combination in additional patients and I look forward to the opportunity to further evaluate MTL-CEBPA."

In three patients investigators initiated off-study treatment with tyrosine kinase inhibitors, 0 – 3 months after completion of on-study treatment with MTL-CEBPA. Two patients administered with sorafenib experienced confirmed complete tumour responses together with marked decreases in alpha-fetoprotein tumour marker. One of these two patients also experienced resolution of both lung and peritoneal metastases. One patient administered with lenvatinib experienced a partial tumour response. In a published Phase III study of sorafenib as a single agent, complete responses were observed in 0% of patients and partial responses were observed in 2% of patients1. In a published Phase III study of lenvatinib as a single agent, complete responses were observed in 0% of patients and partial responses were observed in 18% of patients based on RECIST 1.1 criteria2.

"These exciting observations by study investigators together with an emerging understanding of the role of CEBPA in the tumour immune microenvironment present the opportunity to evaluate a novel regimen with disease modifying potential," said Robert Habib, CEO of MiNA Therapeutics. "Having characterised in patients the safety, tolerability and saRNA proof of mechanism in a single agent setting, MTL-CEBPA is well positioned for further investigation in combination with other cancer therapies. We are in active discussions with the regulatory authorities to amend our ongoing Phase I trial to include further studies of MTL-CEBPA in combination."

The potential for MTL-CEBPA to enhance the benefits of other cancer therapies is supported by emerging pre-clinical research. In a chemically induced model of cirrhotic hepatocellular carcinoma in rats, treatment of MTL-CEBPA for one week followed by sorafenib for one week demonstrated a significant improvement in anti-tumour activity compared to either two weeks of sorafenib alone or two weeks of MTL-CEBPA alone. Durable activity of MTL-CEBPA for several weeks after treatment was previously demonstrated in pre-clinical models of liver disease3.

In 2017 the National Cancer Institute reported pre-clinical studies demonstrating that loss of function of C/EBP-α resulted in an increase in Myeloid Derived Suppressor Cells (MDSCs) in the tumour immune microenvironment resulting in augmented tumour growth in mouse models of cancer4. MDSCs have been identified as key players in promoting a range of diseases, including in cancer where MDSCs may provide tumours resistance to cancer therapies.

The Phase I clinical trial of MTL-CEBPA is ongoing at multiple sites in the United Kingdom and Asia. Enrolment has been completed evaluating MTL-CEBPA as a single agent. Enrolment is expected to begin in Q4 2018 evaluating MTL-CEBPA in combination with sorafenib. For more information, please contact us at [email protected].

About MTL-CEBPA
MTL-CEBPA consists of a double stranded RNA formulated into a SMARTICLES liposomal nanoparticle and is designed to activate the CEBPA gene. By restoring CEBPA expression to normal levels, MTL-CEBPA has been demonstrated to attenuate or reverse liver disease in a range of pre-clinical studies including models of liver cancer, liver cirrhosis, non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). MTL-CEBPA is currently under evaluation in OUTREACH, a multi centre first-in-human Phase I clinical study in

patients with severe liver cancer. In preliminary results from the OUTREACH study, MTL-CEBPA was generally well tolerated in patients with both healthy and impaired liver function was found to mediate RNAa activity in white blood cells. To learn more about the OUTREACH clinical study, please visit our listing at clinicaltrials.gov

On September 19, 2019 Cotinga Pharmaceuticals Inc. (TSX Venture: COT; OTCQB: COTQF) ("Cotinga" or the "Company"), a clinical-stage pharmaceutical company advancing a pipeline of targeted therapies for the treatment of cancer, reported that Richard Ho, M.D., Ph.D., Chief Scientific Officer, will present data on COTI-2, Cotinga’s lead compound currently in a Phase 1b/2a trial, at the 11th International Symposium on Translational Research in Oncology taking place September 27-29, 2018 in Dublin, Ireland (Press release, Cotinga, SEP 19, 2018, View Source [SID1234533151]).

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!

Presentation Title: COTI-2: preclinical and early clinical results from an orally available small molecule targeting mutant p53
Presentation Date and Time: Saturday, September 29, 2018 11:45 AM – 12:15 PM Irish Standard Time
Presentation Location: Landsdowne Suite, Herbert Park Hotel, Ballsbridge, D4

Phase 1b/2a Trial of COTI-2
The ongoing trial focuses on evaluating COTI-2 as a combination therapy for the potential treatment of a wide spectrum of cancers. In 2017, the Company announced top-line data from the gynecological malignancies arm of the trial demonstrating monotherapy with COTI-2 was generally safe and well-tolerated. Monotherapy with COTI-2 also exhibited an encouraging pharmacokinetic/pharmacodynamic profile and signals of efficacy.

Primary outcome measures will evaluate safety and tolerability and determine the maximum tolerated dose and recommended Phase 2 dose for COTI-2 as a combination therapy. Secondary and exploratory outcome measures will evaluate pharmacokinetics and various signals of efficacy. Additional details are available on clinicaltrials.gov.

1stOncology™, the leading oncology drug development surveillance and analysis platform from BioSeeker Group, now fully supports the latest release of the GLOBOCAN database (September 2018) which includes estimates of the incidence, mortality and prevalence from 36 types of cancer and for all cancers combined in 185 countries of the world. The estimates are presented for 2018, separately for each sex and for the 18 traditional age-groups.

The online tool allows the production of tables and visual descriptions of the current cancer burden by country or region, and permits projections regarding future cancer burden over the next 20 years.

Log-in here to access GLOBOCAN 2018 Epidemiology Data in 1stOncology™ or, if you are not a current user, request a free demo here to learn more.

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!