On January 28, 2020 Ikena Oncology, a clinical-stage biotechnology company that discovers and develops patient-directed, biomarker-driven therapies, reported dosing of the first patient in the first Phase 1 clinical trial evaluating IK-175 (formerly KYN-175), an internally-developed, orally administered, selective aryl hydrocarbon receptor (AHR) antagonist, in patients with advanced solid tumors (Press release, Ikena Oncology, JAN 28, 2020, View Source [SID1234553626]). This Phase 1 study is expected to enroll approximately 50 patients in the US across both the dose escalation and dose expansion portions of the study.

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This first-in-human, single-arm, open-label, dose-escalation and expansion study (NCT04200963) is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of IK-175 as a single-agent in patients with locally advanced or metastatic solid tumors, including urothelial carcinoma. The primary objectives of the study include determination of the maximum tolerated dose, characterizing dose-limiting toxicities, and identification of the recommended Phase 2 dose of single-agent IK-175. Secondary objectives include evaluating disease response, including overall response rate, progression-free survival, duration of treatment, disease control rate and duration of response, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Jason Luke, MD, FACP, associate professor of medicine in the Division of Hematology/Oncology and director of the Cancer Immunotherapeutics Center at the University of Pittsburg Medical Centre (UPMC) Hillman Cancer Immunology and Immunotherapy Program, and a clinical investigator on the IK-175 study, commented: "Activated AHR prevents immune recognition in a range of cancers which makes it a highly evocative drug target, especially in patients who do not fully benefit from standard-of-care, including checkpoint inhibitors. Compelling preclinical evidence supports the clinical potential of IK-175, including its ability to potently inhibit AHR activity. We look forward to further elucidating the safety, tolerability and preliminary efficacy of IK-175 in the clinic."

"Advancing IK-175 into the clinic, less than 3 years after we initiated the discovery program, is a key milestone for Ikena and we are delighted to commence investigation of this promising agent in patients with advanced solid tumors," said Mark Manfredi, Ph.D., President and Chief Executive Officer of Ikena Oncology. "This accelerated timeline is a testament to our ability to rapidly advance assets from the bench to patients. Assuming a positive outcome from the dose-escalation and expansion portion of this single-agent study, we plan to commence an additional portion of the study to evaluate IK-175 in combination with a checkpoint inhibitor. We look forward to providing updates over the course of the study."

About IK-175

IK-175 (formerly known as KYN-175) is an internally-developed, orally-administered, selective aryl hydrocarbon receptor (AHR)antagonist which prevents AHR-modulated tumor promotion through its influence on both the tumor and the immune system. Ikena Oncology recently commenced a first-in-human, Phase 1 clinical study (NCT04200963) in which the safety and antitumor activity of IK-175 is being evaluated as a single agent in advanced solid tumors. A patent application with claims directed to IK-175 has been allowed by the United States Patent and Trademark Office. The AHR antagonist program is the subject of a global strategic collaboration with Bristol-Myers Squibb.

On January 28, 2020 MSD, tradename of Merck & Co., Inc., Kenilworth, N.J., USA (NYSE: MRK), reported preliminary results from a study carried out by The Economist Intelligence Unit (The EIU) on lung cancer, which show a fragmented policy approach across Europe (Press release, Merck & Co, JAN 28, 2020, View Source [SID1234553625]). The study underlines that awareness needs to be addressed on multiple fronts to fight the stigma associated with this disease and to ensure patients receive timely access to the best possible care. The data were presented days before the European Commission’s official launch of the stakeholders’ consultation on Europe’s Beating Cancer Plan.

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"There is no room for complacency in lung cancer; 1 out of 5 of all cancer deaths in Europe is caused by lung cancer and it kills as many Europeans as breast, colon and prostate cancer combined. The study uncovers actionable solutions to empower countries and their health systems to better manage lung cancer, and ultimately, improve the lives of people living with a diagnosis of this treatable disease," commented Mary Bussell, Associate at The Economist Intelligence Unit.

The study shows that of the 27 countries participating, 15% (4 countries) do not have a National Cancer Control Plan (NCCP). 14 countries with existing NCCPs have not updated them within the past five years, and only one has a lung cancer-specific control plan.

National Lung Cancer Clinical Guidelines (NLCCGs) should include timeframes for fast-tracking people suspected of having lung cancer for diagnostic testing and provide a rapid referral for secondary or tertiary treatment for those diagnosed with lung cancer. Although 26 of the 27 countries covered in the study have national clinical guidelines for lung cancer, discrepancies remain:

11 countries do not include fast-tracking of suspected lung cancer patients to receive diagnostic testing;
12 do not include a timeframe within which diagnostic testing should be given to suspected lung cancer patients;
15 do not include rapid referral to secondary or tertiary care, once a diagnosis of lung cancer has been made; and
3 countries do not include fast-tracking for diagnosis within timeframes or rapid referral to secondary or tertiary care in their lung cancer clinical guidelines. However, they are included in government policies, national agreements, or are mandated by law.
"The presentation of this data is quite timely. While Europe has agreed on the need for a European Cancer Plan, the study draws attention to specific issues around lung cancer and its burden. Clearly, prevention and health promotion have important roles to play. At the same time, we know that early detection and fast referral to treatment are crucial to improve patient outcomes – lung cancer is a race against time. The study shows that we have plenty of work to do there," said Deepak Khanna, Senior Vice President and Regional President Oncology for Europe, Middle East, Africa and Canada, MSD.

"The data presented helps us understand the specificities of lung cancer better. As we design a European Cancer Plan aiming at reducing the cancer burden for patients, their families and health systems, and addressing cancer related inequalities, it is important to gather available information on best practices and knowledge from research and clinical experience, that can help us build a robust evidence base for better policy making", added Martin Seychell, Deputy Director General, DG SANTE, European Commission.

About the Study

The study analysed 17 performance indicators across 27 countries – Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, the Netherlands, Norway, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. The indicators were categorised into five domains focused on the degree to which a country considers lung cancer to be a strategic priority and a public health issue, ensures timely diagnostic and treatment services and the quality of cancer registries which can help to facilitate high-quality research. Each country received a score for all 17 indicators. Once draft scores were assigned to each country, national workshops were conducted with external country-based experts to discuss the findings and develop recommendations for policy and programme improvements. Preliminary results of the first phase of the study were presented at the 2018 European Cancer Forum in Brussels. An additional 16 countries are being analysed and the preliminary results of this second phase were presented at the 2020 European Cancer Forum in Brussels. The final report with a full analysis of the results is expected in Spring 2020. The Economist Intelligence Unit benchmarking study is supported by MSD. Editorial decisions are the responsibility of The Economist Intelligence Unit.

About Lung Cancer

Lung cancer, which forms in the tissues of the lungs, usually within cells lining the air passages, is the leading cause of cancer death worldwide. According to WHO, in 2018 470,000 Europeans were diagnosed with lung cancer, and 388,000 Europeans died of the disease that year. The two main types of lung cancer are non-small cell and small cell. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for about 85% of all cases. Small cell lung cancer (SCLC) accounts for about 10 to 15% of all lung cancers.

On January 28, 2020 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biotechnology company specializing in the development of novel treatments for brain tumors, reported that Anthem Biosciences of Bangalore, India (Anthem) has completed a pilot run of the recrystallization of the Reata Pharmaceuticals, Inc. API (Reata) (Press release, CNS Pharmaceuticals, JAN 28, 2020, View Source [SID1234553624]). It has also completed a lyophilization of the API. Samples of the drug product, which include 299 capped vials, have been shipped to Intertek Pharmaceutical Services (Intertek) for further analysis and release.

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As previously announced, the FDA agreed in a preclinical submission that CNS could use Reata API as long as it was reprocessed and released under GMP conditions, and that the new lyophilized form of the drug product could be used during the Company’s upcoming clinical trial. Anthem, a full-service provider of GMP manufacturing for APIs, completed this pilot run of the Reata API. The pilot run recrystallization passed all specifications at Intertek. The recrystallized API was shipped to Lyophilization Technology, Inc. a leader of GMP lyophilization of Drug Products for clinical trials, which completed a pilot lyophilization. The pilot run of lyophilized API was successfully tested and released by Intertek. DavosPharma, a Davos Chemical Company, acted on behalf of the Company as the coordinating manufacturing broker for all of these processes.

"We are excited to achieve another important milestone in the development of Berubicin," stated John Climaco, CEO of CNS Pharmaceuticals. "We look forward to completing both GMP manufacturing processes and release for clinical trials."

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.

On January 28, 2020 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics (MBTs) to treat chronic diseases and extend healthy lifespan, reported that its Chief Executive Officer, Steven Engle, will present a company update at the 2020 BIO CEO & Investor Conference, which is being held February 10-11 at the Marriott Marquis in New York (Press release, CohBar, JAN 28, 2020, View Source [SID1234553623]). Now in its 22nd year, the BIO CEO & Investor Conference is one of the largest independent investor conferences focused on established and emerging publicly traded and select private biotech companies.

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Presentation Details
Monday, February 10 at 3:30 PM ET
New York Marriott Marquis, Wilder Room

Webcast
The presentation may be accessed via webcast at the scheduled time, or following the presentation, using the following link: https://veracast.com/webcasts/bio/ceoinvestor2020/33129128834.cfm.

On January 28, 2020 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported the appointment of Dr. Laurence De Moerlooze to the position of Executive Vice President and Chief Medical Officer (CMO) (Press release, Bavarian Nordic, JAN 28, 2020, View Source [SID1234553622]). Dr. De Moerlooze joins Bavarian Nordic from Takeda Vaccines, where she has served since 2017 as Vice President and Global Program Lead for vaccines against Zika virus and Norovirus.

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Prior to joining Takeda, she worked at GlaxoSmithKline (GSK) for more than 15 years, holding various leading roles in medical affairs and vaccine development working with numerous life-saving vaccines including Rabipur/Rabavert and Encepur.

Dr. De Moerlooze will take up the position in April 2020.

"I am pleased to welcome Laurence to Bavarian Nordic and to our executive team. Laurence brings a wealth of knowledge from the vaccine industry and will add important and valuable R&D and commercial experience to our company as we continue to expand our business," said Paul Chaplin, President and CEO of Bavarian Nordic.

"I am delighted to join Bavarian Nordic at such a key time for the Company. I look forward to putting my experience and commitment to the service of the organization in the development of life-saving vaccines and immunotherapies. I am also eager to help bring the newly acquired rabies and tick-borne encephalitis vaccines to patients who need them most," said Laurence De Moerlooze.