Immunovia and Global Pharmaceutical Company Agree on Early Termination of Lung Cancer Collaboration

On April 8, 2020 Immunovia AB (publ) ("Immunovia") reported that the company’s Lung Cancer collaboration with a global pharmaceutical company has been terminated (Press release, Immunovia, APR 8, 2020, View Source [SID1234556220]).

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Immunovia’s own early detection program in lung cancer continues as planned and the company has received the necessary fresh blood samples from the pharma partner for testing and analysis. Immunovia’s study is on track and will be finished in Q2 2020 as planned.

This is information that Immunovia is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 8:45 CET on April 8, 2020.

CTI BioPharma to Present at the Needham Healthcare Conference on Wednesday, Apr. 15

On April 8, 2020 CTI BioPharma Corp. (CTI BioPharma) (NASDAQ: CTIC) reported that management will provide a corporate overview at the Needham Healthcare Conference at 10:40 a.m. EDT (Press release, CTI BioPharma, APR 8, 2020, View Source [SID1234556219]). The conference will be held in a virtual meeting format.

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Presentation details:

Event:

Needham Healthcare Conference

Date:

Wednesday, Apr. 15

Time:

10:40 a.m. EDT

The presentation will be webcast live and available for replay from the Investors section of CTI BioPharma’s website at www.ctibiopharma.com.

Prime Therapeutics Welcomes Joseph Leach, M.D. as Chief Medical Officer

On April 8, 2020 Prime Therapeutics LLC (Prime), a pharmacy benefit manager (PBM) reported that serving more than 30 million members nationally, has named Joseph Leach, M.D., as senior vice president and chief medical officer (CMO) (Press release, Prime Therapeutics, APR 8, 2020, View Source [SID1234556217]). Dr. Leach brings over 20 years of experience as a clinician, researcher and health care leader to his role. He will lead the expansion of Prime’s specialty management capabilities and help shape the company’s total drug management strategy.

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Dr. Leach will partner with Blue Plan medical directors and pharmacy leaders to drive adoption of specialty and total drug management solutions. Dr. Leach brings deep experience as a medical oncologist and researcher to help the company’s clients and members navigate an era when million-dollar curative therapies – many in the oncology space – are coming to market.

He has held numerous leadership roles including medical director of Virginia Piper Cancer Institute in Minneapolis, past president of the Minnesota Society of Clinical Oncology and principal investigator for the Metro-Minnesota Community Oncology Research Consortium.

Dr. Leach has also held national leadership positions in research including committee chair for the Eastern Cooperative Oncology Group (ECOG), which was one of the first publicly funded cooperative groups to perform multi-center clinical trials for cancer research. He was appointed to the NCI Thoracic Malignancy Steering Committee, an organization that directs the national research priorities and approves clinical trial concepts for lung cancer research.

"I couldn’t be more pleased to welcome Dr. Leach to Prime," said Prime’s President and CEO, Ken Paulus. "Dr. Leach’s depth of experience in oncology therapy coupled with his devotion to patient-focused care will offer superb value to our clients and their members. He is highly respected in the medical world and I’m certain Dr. Leach is the best person to help us navigate the complex and important work associated with managing the cost and use of revolutionary new treatments for complex illnesses."

"I’m delighted to join the team at Prime and to work with their Blue Plan clients to advance the company’s total drug management vision," said Dr. Leach. "I hope that my perspective as a physician, working with patients fighting devastating illnesses like cancer, can help keep us focused on our most important mission."

Dr. Leach holds a Bachelor of Arts degree in biology from St. Olaf College in Northfield, Minn. and earned a Doctor of Medicine degree from the University of Minnesota in Minneapolis. He completed training in internal medicine and medical oncology at the University of Oklahoma in Oklahoma City and is a board-certified medical oncologist.

T-Cure Bioscience Signs Exclusive Worldwide License With NCI for the Development of T Cell Receptor Therapy for Treatment of Solid Tumors

On April 8, 2020 T-Cure Bioscience, Inc., a privately held company focused on developing autologous T cell receptor (TCR) therapy products for the treatment of solid tumors, reported that the Company has entered into an exclusive, worldwide license with the National Cancer Institute (NCI) for intellectual property related to a TCR-based product candidate for the treatment of tumors expressing Kita-Kyushu lung cancer antigen 1 (KK-LC-1), for the treatment of KK-LC-1-expressing malignancies, such as gastric, lung, and breast cancers (Press release, T-Cure Bioscience, APR 8, 2020, View Source [SID1234556216]). T-Cure anticipates the KK-LC-1 TCR therapy will enter a multi-site Phase 1 clinical study in the second quarter of 2020 under the direction of Christian S. Hinrichs, M.D., Principal Investigator at the Experimental Transplantation and Immunology Branch (ETIB) at NCI.

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To support the preclinical and clinical research to develop the TCR product and future products targeting KK-LC-1, T-Cure has entered into a Cooperative Research and Development Agreement (CRADA) with the NCI. Under the CRADA, T-Cure will work to identify additional therapy candidates targeting KK-LC-1 using the Company’s proprietary TCR discovery platform, iSORT. The Company also intends to conduct an independent Phase 1 clinical trial in 2021 to further assess the safety and efficacy of the licensed KK-LC-1 TCR.

"The KK-LC-1 TCR technology forms the foundation of a new treatment strategy for a certain common, difficult to treat cancers," stated NCI’s Dr. Hinrichs.

"We are extremely excited to work with Dr. Hinrichs and his team at NCI to advance this novel TCR product candidate through preclinical and clinical development," stated Gang Zeng, Ph.D., Chief Executive Officer of T-Cure. "Dr. Hinrichs’ extensive experience in the discovery and development of novel adoptive T-cell therapies for cancer will be invaluable as we advance this program. Of note, the TCR was isolated from the tumor-infiltrating lymphocytes of a patient who had a complete response to an immunotherapy without any toxicities. As a result, we believe it holds great promise for engineering patients’ immune cells to effectively target and destroy cancer cells without harming healthy tissue."

AIVITA Biomedical Provides Update of Ongoing Phase 2 Glioblastoma Trial from Year-End Survival Analysis

On April 8, 2020 AIVITA Biomedical, Inc., a biotechnology company specializing in innovative cell therapy applications, reported that survival data from a year-end analysis of its ongoing Phase 2 clinical trial of AV-GBM-1 in patients with newly diagnosed glioblastoma (GBM) (Press release, AIVITA Biomedical, APR 8, 2020, View Source [SID1234556215]).

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In the analysis, the overall survival rate at both 12 and 15 months is 76% in AV-GBM-1-treated patients (n=50), compared to overall survival of 61% at 12 months and 48% at 15 months in control patients (n=287) receiving standard of care. Patient recruitment is complete in the study, with 55 patients enrolled across eight trial sites. Additional details are available through ClinicalTrials.gov.

"Although treatment and monitoring of patients is ongoing, we are very encouraged by these interim results," said Dr. Robert O. Dillman, AIVITA Chief Medical Officer. "We completed accrual to the trial ahead of schedule, thanks to the engagement of our clinical site principal investigators and a truly outstanding manufacturing success rate at AIVITA."

AV-GBM-1 is a novel immunotherapy consisting of autologous dendritic cells loaded with autologous tumor antigens derived from self-renewing tumor-initiating cells. The treatment is administered in a series of subcutaneous injections as an adjunctive therapy. The treatment is uniquely pan-antigenic, targeting multiple antigens on autologous tumor-initiating cells responsible for the rapid growth of the disease and resistance to standard therapy.

AIVITA is currently conducting three clinical studies in the United States investigating its platform immunotherapy in patients with ovarian cancer, glioblastoma and melanoma. In a past clinical trial in metastatic melanoma, AIVITA’s autologous dendritic cells has demonstrated 72% 2-year survival and 54% 5-year survival in patients (n=92). Based on data, AIVITA is currently seeking conditional commercial approval of its melanoma treatment in Japan. The clinical trial in advanced ovarian cancer is a Phase 2 randomized study currently enrolling patients at the time of initial diagnosis.

About AIVITA’s Clinical Trials

OVARIAN CANCER

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 tumor-initiating 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. The trial is not open to patients with recurrent ovarian cancer.

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

GLIOBLASTOMA

AIVITA’s glioblastoma Phase 2 single-arm study is active and is enrolling approximately 55 patients to receive the tumor-initiating 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). The trial is not open to patients with recurrent glioblastoma.

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

MELANOMA

AIVITA’s melanoma Phase 1B open-label, single-arm study will establish the safety of administering anti-PD1 monoclonal antibodies in combination with AIVITA’s tumor-initiating 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. This trial is not yet open for enrollment.

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