On March 1, 2019 Applied DNA Sciences Inc. (NASDAQ: APDN) ("Applied DNA"), a leader in large-scale PCR-based DNA manufacturing, reported that LineaRx, Inc. ("LineaRx"), its wholly-owned subsidiary focused on next-generation biotherapeutics, will ship TK7 and ConTRT amplicons to Takis/Evvivax next week as part of the companies’ Joint Development Agreement ("JDA") entered into in September 2018 (Press release, Applied DNA Sciences, MAR 1, 2019, View Source [SID1234533907]).

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Per the JDA, LineaRx and Takis/Evvivax will jointly develop linear DNA expression amplicons for TK7 and ConTRT, two of Takis/Evvivax’s anti-cancer vaccine candidates, utilizing LineaRx’s validated linear DNA technology. Linear DNA amplicons carrying the DNA sequences for Takis/Evvivax vaccine candidates will be delivered to pre-clinical animal models via Takis/Evvivax’s proprietary electroporation technology.

In 2018, LinearRx and Takis/Evvivax’s collaboration showed immunogenicity in mice that were vaccinated with linear DNA against the human protein telomerase that is over-expressed in more than 85% of all cancers. "This year we are using ConTRT, an improved version of our telomerase vaccine and a unique personalized approach which includes an epitope-prediction pipeline and a delivery strategy to achieve an extremely effective cancer vaccine over what has been done previously," said Dr. Luigi Aurisicchio, CEO of Takis/Evvivax. "Each expression amplicon will undergo rigorous quality subject matter testing, immunogenicity testing, followed by a tumor challenge, with results planned for publication later this year."

"Our collaborations with Takis/Evvivax and other therapy developers are helping to validate LineaRx’s novel technology as a viable alternative to bacterially-produced plasmids, with the potential for increased patient safety and reduced costs, using new quality control protocols for large-scale PCR production at LineaRx. We believe that linear DNA and the establishment of new quality attributes for this new therapeutic field will change the way gene and immune therapies will be performed," stated Dr. James Hayward, president and CEO of Applied DNA. "Our implementation of testing for new quality attributes will support our preparation to approach FDA to seek approval for clinical study. Our know-how in the fields of therapeutic linear DNA production and the standardized PCR platforms in use at LineaRx enable us to create novel expression amplicons. We are extremely pleased with the progress we are making with Takis/Evvivax under our JDA."

On March 1, 2019 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that it will host a conference call and live webcast for Analysts and Institutional Investors at 8:30 a.m. ET on Friday, March 8, 2019 following release of its year end 2018 financial results (Press release, Oncolytics Biotech, MAR 1, 2019, https://ir.oncolyticsbiotech.com/news/detail/448/oncolytics-biotechr-to-host-conference-call-to-discuss-year-end-financial-results-and-operational-highlights [SID1234533905]).

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The live call may be accessed by dialing (877) 407-9205 for callers in North America. Overseas callers should contact investor relations for the toll-free dial information for their country. A replay of this call will be available approximately two hours after the call is ended at (877) 481-4010, using the replay code 44902 and will be available for one week. A live webcast of the call will be accessible on the Investor Relations page of Oncolytics’ website at www.oncolyticsbiotech.com and will be archived for three months.

On March 1, 2019 CARsgen Therapeutics, a clinical-stage company committed to developing Chimeric Antigen Receptor T cell therapies for cancer, reported that one of its leading drug candidates, CT053 fully human BCMA (B-Cell Maturation Antigen)-CAR-T cell for the treatment of patients suffering from relapsed/refractory multiple myeloma (rrMM), has received Investigational New Drug (IND) clearance from the National Medical Products Administration (NMPA) (Press release, Carsgen Therapeutics, MAR 1, 2019, View Source [SID1234533883]).

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"At the American Society of Hematology (ASH) (Free ASH Whitepaper) meeting in December 2018, our collaborator, Dr. Songfu Jiang presented encouraging safety and efficacy data in patients with rrMM who received CT053 BCMA-CAR-T cells. The IND clearance of BCMA-CAR-T cells by China’s NMPA is of great significance to CARsgen," said Dr. Zonghai Li, founder, CEO and CSO of CARsgen. "According to JAMA Oncology, in 2016, there were about 130,000 cases of myeloma, which means from 1990 to 2016, incident cases of myeloma increased by 126% globally[1] and despite the development of novel therapies, multiple myeloma remains incurable and new treatment options are needed. As part of the CT053 development plan, we also intend to submit an IND application for BCMA-CAR-T cells to the U.S. FDA in 2019. Our goal is to continue the development of novel, safe and effective immunotherapies. This is our long-standing commitment to cancer patients worldwide."

On March 1, 2019 AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, reported that the Company will be presenting mechanism of action findings and study design details at the 2019 ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium taking place February 28 to March 2 in San Francisco, CA (Press release, AIVITA Biomedical, MAR 1, 2019, View Source [SID1234533882]). Chief Science Officer Dr. Gabriel Nistor will present a poster concerning Th17 responses to an autologous immunotherapy targeting cancer stem cells. Chief Medical Officer Dr. Robert O. Dillman will present a poster concerning AIVITA’s randomized Phase 2 trial of patient-specific immunotherapy targeting cancer stem cells.

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The ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium is a three-day meeting focused on clinical and translational research in immune-oncology. Dr. Nistor’s poster presentation will take place March 1 in Poster Session B of the Melanoma/Skin Cancers track. It will highlight how an autologous cancer immunotherapy can induce a Th17 phenotype preceding a Th1 type response. The findings are important for applications in settings in which tumor infiltration with Th17+ cells correlate with survival, such as in advanced ovarian cancer.

Dr. Dillman’s poster presentation will take place March 1 in Poster Session B of the Breast and Gynecologic Cancers track. It will inform attendees of the design and methodologies of AIVITA’s active Phase 2 clinical trial for ovarian cancer. The trial was initiated in November 2017 at a single site and has thus far received 11 appropriate patient tumor samples, with all 11 having successfully been expanded into viable cell lines for use in the creation of the Company’s autologous vaccine. Additional clinical sites are being initiated.

AIVITA is currently conducting three clinical studies investigating its platform ROOT OF CANCER therapy in patients with ovarian cancer, glioblastoma and melanoma. AIVITA uses 100% of proceeds from the sale of its ROOT of SKIN skincare line to support the treatment of women with ovarian cancer.

About ROOT OF CANCER

AIVITA’s treatment is a platform technology applicable to most solid tumor types and consists of autologous dendritic cells loaded with autologous tumor antigens from purified autologous self-renewing tumor-initiating cells.

AIVITA’s ovarian Phase 2 double-blind study is active and enrolling approximately 99 patients who are being randomized in a 2:1 ratio to receive either the autologous cancer stem cell-targeting immunotherapy or autologous monocytes as a comparator.

Patients eligible for randomization and treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis from which sufficient monocytes were obtained, (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), and (5) who have completed primary therapy.

For additional information about AIVITA’s AVOVA-1 trial patients can visit: www.clinicaltrials.gov/ct2/show/NCT02033616

AIVITA’s glioblastoma Phase 2 single-arm study is active and is enrolling approximately 55 patients to receive the cancer stem cell-targeting immunotherapy.

Patients eligible for treatment will be those (1) who have recovered from surgery such that they are about to begin concurrent chemotherapy and radiation therapy (CT/RT), (2) for whom an autologous tumor cell line has been established, (3) have a Karnofsky Performance Status of > 70 and (4) have undergone successful leukapheresis from which peripheral blood mononuclear cells (PBMC) were obtained that can be used to generate dendritic cells (DC).

For additional information about AIVITA’s AV-GBM-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03400917

AIVITA’s melanoma Phase 1B open-label, single-arm study will establish the safety of administering anti-PD1 monoclonal antibodies in combination with the cancer stem cell-targeting immunotherapy in patients with measurable metastatic melanoma. The study will also track efficacy of the treatment for the estimated 14 to 20 patients.

Patients eligible for treatment will be those (1) for whom a cell line has been established, (2) who have undergone leukapheresis from which sufficient monocytes were obtained, (3) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), (4) who have either never received treatment for metastatic melanoma or were previously treated with enzymatic inhibitors of the BRAF/MEK pathway because of BRAF600E/K mutations and (5) are about to initiate anti-PD1 monotherapy.

For additional information about AIVITA’s AV-MEL-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03743298

On March 1, 2019 Compugen Ltd. (NASDAQ: CGEN), a clinical-stage cancer immunotherapy company and leader in predictive target discovery, reported that its Phase 1 clinical trial evaluating COM701, a first-in-class therapeutic antibody targeting PVRIG, was featured in a trial-in-progress at The ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium (Press release, Compugen, MAR 1, 2019, View Source [SID1234533881]). In poster titled "A Phase 1 Study Evaluating COM701 in Patients With Advanced Solid Tumors," the Company reported that the third single subject dose cohort has been completed with no dose-limiting toxicities (DLTs) reported. Clinical and laboratory assessment for safety and tolerability is ongoing for the fourth dosing cohort. The poster presented at the symposium is available on Compugen’s website.

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"We continue to see significant interest in the study from investigators as they recognize the potential and differentiation of COM701 relative to other checkpoint inhibitors in development," said Henry Adewoye, M.D., Chief Medical Officer at Compugen. "After recently adding Massachusetts General Hospital and the University of Chicago, two additional leading medical centers with significant experience in immuno-oncology, we now have five sites recruiting patients for this Phase 1 study. Patient enrollment is also on track and we expect to complete enrollment of both the monotherapy and dual combination dose escalation arms of the study this year."

The sites currently recruiting patients are: The START center in San Antonio, Texas; The University of Tennessee West Cancer Center in Memphis, Tennessee; Sarah Cannon Research Institute in Nashville, Tennessee; Massachusetts General Hospital in Boston, Massachusetts; and the University of Chicago in Chicago, Illinois. The study is expected to include up to ten sites and enroll approximately 140 patients.

Updated information on the COM701 Phase 1 clinical study will be next featured in a trial-in-progress poster at The AACR (Free AACR Whitepaper) Annual Meeting 2019 taking place March 29-April 3, 2019 at the Georgia World Congress Center, Atlanta, GA.

About the COM701 Phase 1 Study

This Phase 1 open-label clinical trial is designed to assess the safety and tolerability of administering escalating doses of COM701 monotherapy as well as combination administration with a PD-1 inhibitor in patients with advanced solid tumors. Additionally, the trial will evaluate evidence of preliminary antitumor activity of COM701 as a monotherapy as well as in combination with a PD-1 inhibitor in patients with selected tumor types, including non-small cell lung cancer, ovarian cancer, breast cancer and endometrial cancer. Additional information is available here.