On March 3, 2020 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, reported as of February 2020, a patient from the Phase 1 clinical trial for the treatment of glioblastoma multiforme ("GBM"), conducted by Reata Pharmaceuticals, Inc., remains cancer free. GBM is an aggressive type of brain cancer and, currently, there are no effective therapies approved to treat this disease (Press release, CNS Pharmaceuticals, MAR 3, 2020, View Source [SID1234555155]).

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In the Phase 1 trial, 44% of patients experienced a statistically significant improvement in progression-free survival. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response, which is defined by the National Cancer Institute as the disappearance of all signs of cancer in response to treatment. This initial trial was conducted in 2006 and as of February 2020, the patient has remained cancer free for over 13 years.

"We are delighted to provide this update on Berubicin’s potential capabilities given the unmet need for this aggressive disease," commented John M. Climaco, Chief Executive Officer of CNS Pharmaceuticals. "We are looking forward to initiating our Phase 2 clinical trial in the second half of this year with our partner, WPD Pharmaceuticals, Inc. In addition, we expect WPD Pharmaceuticals, Inc. to commence a first-ever Phase 1 trial in children later this year. As previously announced, the pediatric trial will be conducted at Children’s Memorial Health Institute, the largest pediatric hospital in Poland." WPD Pharmaceuticals, Inc. was founded by Dr. Waldemar Priebe, the founder of the Company.

About Berubicin
Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata Pharmaceuticals, Inc.

On March 3, 2020 Sunesis Presented the corporate presentation (Press release, Sunesis, MAR 3, 2020, View Source [SID1234555100]).

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On March 3, 2020 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company’s lead drug candidate, tipifarnib, for the treatment of adult patients with relapsed or refractory angioimmunoblastic T-cell lymphoma (AITL), follicular T-cell lymphoma (FTCL) and nodal peripheral T-cell lymphoma with T follicular helper (TFH) phenotype (Press release, Kura Oncology, MAR 3, 2020, View Source [SID1234555122]).

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"This important designation from the FDA comes just two months after tipifarnib was awarded Fast Track for the treatment of patients with HRAS mutant head and neck squamous cell carcinomas (HNSCC)," said Bridget Martell, M.A., M.D., Acting Chief Medical Officer of Kura Oncology. "We believe that this designation reflects tipifarnib’s significant potential in these devastating disease settings, and we are now actively preparing to initiate a second registration-directed trial of tipifarnib in advanced nodal lymphomas of TFH phenotype, including AITL."

Fast Track designation is granted by the FDA for products that are intended for the treatment of serious or life-threatening disease or conditions, which demonstrate the potential to address an unmet medical need. The designation offers the opportunity for frequent interactions with the FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval, as well as eligibility for rolling submission of a New Drug Application.

In December 2019, Kura reported updated clinical data at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting showing robust and durable activity from tipifarnib as a monotherapy in relapsed or refractory AITL. The data demonstrated an objective response rate (ORR) of approximately 50% in a heavily pre-treated patient population, with a median of three prior regimens. Additionally, enhanced anti-tumor activity was observed in patients who carried mutations in the killer-cell immunoglobulin-like receptor, or KIR, a CXCL pathway-associated biomarker. These patients had an ORR of 70% and a complete response rate of 40%.

About T-Cell Lymphomas

Peripheral T-cell lymphomas compromise up to 20% of all aggressive non-Hodgkin lymphomas and consist of many different subtypes of fast-growing lymphomas, representing approximately 20,000 incident cases per year worldwide. Outcomes for these patients are poor, with 5-year survival of approximately 30%. Although several drugs have been approved in the relapsed and/or refractory setting, none has led to a survival benefit. In addition, the National Comprehensive Cancer Network guidelines currently recommend clinical trials for these patients. Significant advances in the genetic landscape of T-cell lymphomas have led to revisions to the World Health Organization classification and the introduction of new entities. As a result, cases of AITL, an aggressive form of T-cell lymphoma frequently characterized by high levels of CXCL12 expression, are now unified with FTCL under the classification of nodal lymphomas of TFH phenotype.

About Tipifarnib

Kura Oncology’s lead drug candidate, tipifarnib, is a potent, selective farnesyl transferase inhibitor in-licensed from Janssen in December 2014. Previously, tipifarnib was studied in more than 5,000 cancer patients, showing compelling and durable anti-cancer activity in certain patient subsets. However, no molecular mechanism of action was determined that could explain its clinical activity across a range of solid tumor and hematologic indications. Leveraging advances in next-generation sequencing and emerging information about cancer genetics and tumor biology, Kura is seeking to identify those patients most likely to benefit from tipifarnib. The Company has received multiple issued patents for tipifarnib in the U.S. and foreign countries, including one issued by the U.S. Patent and Trademark Office in September 2019 that further extends Kura’s exclusivity to the use of any farnesyl transferase inhibitor for the treatment of CXCL12-expressing peripheral T-cell lymphoma and acute myeloid leukemia.

On March 3, 2020 PDC*line Pharma, a clinical stage biotech company developing a new class of potent and scalable active immunotherapies for cancers, reported that the first patient was dosed with its innovative medicinal product candidate PDC*lung01 in a phase I/II trial in non-small cell lung cancer (NSCLC) (Press release, PDC Line Pharma, MAR 3, 2020, View Source [SID1234555139]). This patient is under the supervision of Dr. Anne Sibille, principal investigator for the Liege University Hospital (Belgium).

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The objectives of the phase I/II trial (PDC-LUNG-101) are to assess the safety, tolerability, immunogenicity and preliminary clinical activity of the drug candidate, PDC*lung01, associated or not with anti-PD-1 treatment in NSCLC. A total of 62 evaluable HLA-A*02:01 positive NSCLC patients are expected in three clinical centers in Belgium and six in France.

PDC*lung01 is a cell suspension of a mix, in the same proportion, of seven active agents made of irradiated human plasmacytoïd dendritic cells (PDC*line) loaded separately with a distinct synthetic human leukocyte antigen serotype-restricted peptide (HLA-A*02:01) encoded by a tumour antigen. PDC*line is a potent professional antigen-presenting cell that is able to prime and boost the antitumor cytotoxic CD8+ T-cells in the patient’s immune system.

"We are delighted to have achieved this first important milestone in the clinical development of PDC*line Pharma with our lead cancer vaccine candidate," said Eric Halioua, president and CEO of PDC*line Pharma. "Based on preclinical studies there is a strong rationale for developing PDC*lung01 in this indication and we are currently exploring a number of additional indications, where our technology may provide potential benefit for patients."

"PDC*lung01 is an innovation in the field of cancer vaccines that appears particularly suitable for the treatment of NSCLC patients, an area where there is still a high unmet medical need," said Dr. Channa Debruyne, medical director of PDC*line Pharma.

About lung cancer
Worldwide, lung cancer is the most common malignancy for male patients and for both sexes combined (2.1 million new cases per year), and the third most common for female patients (after breast and colorectal cancers). Globally, deaths from lung cancer exceed those from any other cancer, with the number of lung-cancer-related deaths for 2018 estimated at 18.1 million; 18.4% of total cancer deaths. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, representing 80% of cases.

About PDC*line Pharma’s technology

PDC*line’s biological features provide unique advantages:

A professional antigen-presenting cell line, much more potent than conventional dendritic cells in priming and expanding antitumor-specific cytotoxic CD8+ T cells (conventional tumor antigens and neoantigens)
While allogeneic, PDC*line is not rejected by the host immune system and can be injected several times to boost the immune response
Easily produced on a large scale, with a fully mastered and simple manufacturing process (use of bioreactors with a synthetic medium without growth, differentiation or activation factors)
Easy to use: after thawing, the same off-the-shelf product is used to treat the whole target population with a cancer type expressing the target antigens
Very versatile: tumor antigens can be provided by peptide loading, mRNA transfection or retrovirus transduction of PDC*line and the target population can be extended beyond HLA-A2 (currently used as it is expressed by 50% of the Caucasian population) by using other HLAs, either already expressed by PDC*line or added by genetic modification. Moreover, new candidates can be validated for new cancer indications in a few weeks, with ex vivo testing using human peripheral blood mononuclear cells (PBMC)
Synergizes with anti-PD-1 to activate antitumor CD8 T cells

On March 3, 2020 Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, reported its commitment to achieve a colorectal cancer screening rate for its employees of at least 80% (Press release, Bracco Diagnostics, MAR 3, 2020, View Source [SID1234555156]).

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Colorectal cancer is a major public health problem. Colorectal cancer is the second leading cause of cancer death, and a cause of considerable suffering among more than 145,000 adults diagnosed with colorectal cancer each year. Colorectal cancer screening can reduce colorectal cancer death rates by both preventing the disease through the detection and removal of precancerous polyps and through detection at early more treatable stages.1

The National Colorectal Cancer Roundtable (NCCRT), established by the American Cancer Society (ACS) and the Centers for Disease Control and Prevention (CDC), has evolved their awareness campaign to increase Colorectal Cancer screening rates implementing the 80% in every community initiative in 2019.2

"Bracco Diagnostics Inc. is committed to the health and wellbeing of our employees, not only by taking the 80% screening rate pledge but also providing market leading products that are used in CT Colonography procedures. CT Colonography, also known as CTC or virtual colonoscopy, is a visual, patient-friendly colorectal screening test that can detect both precancerous and cancerous colorectal abnormalities," said Vittorio Puppo, President and CEO of Bracco Diagnostics Inc. "We have proudly supported for many years the great work of the NCCRT, other patient advocacy organizations and the American College of Radiology Colorectal Cancer Committee. At Bracco Diagnostics we are committed to the effort of eradicating colorectal cancer. Consequently, it is a logical step for Bracco Diagnostics to join the growing number of organizations in New Jersey and across the U.S. that make the 80% In Every Community pledge. I encourage other business leaders to join us in making this pledge for their organizations."

To find a location that performs CT Colonography procedures visit the American College of Radiology CT Colonography center locator at View Source