CNS Pharmaceuticals Completes Pilot Manufacturing Steps Pursuant to FDA Pre-IND Guidance

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.

CohBar to Present at the 2020 BIO CEO & Investor Conference

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.

Bavarian Nordic Announces Appointment of Laurence De Moerlooze as Chief Medical Officer

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.

West Recognized as a Top Company for Corporate Responsibility

On January 28, 2020 West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, reported that it was recently named as a Top Company for Corporate Responsibility practices by both Newsweek and Investor’s Business Daily (Press release, West Pharmaceutical Services, JAN 28, 2020, View Source [SID1234553621]).

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Newsweek has named West to its America’s Most Responsible Companies 2020 list. Newsweek’s partner, Statista Inc., who conducted the analysis, focused on areas such as Leadership Diversity, Employees and Philanthropy & Engagement as well as making a difference in local communities. After examining the top 2,000 public companies (by revenue), West was ranked #166 overall as among the "most committed to Corporate Responsibility" and was ranked in the Top 20 among companies in the Health Care & Life Sciences industry. West also ranked #9 overall for companies headquartered in Pennsylvania.

West is also honored to have been ranked #19 on Investor’s Business Daily’s 50 Best ESG Companies list. This recognition honors companies with strong financial performance that hold true to their ESG (environmental, social and governance) values. Among companies with ESG ratings of AAA or AA from MSCI ESG Research as of September 11, 2019, the top 50 recognized companies earned the highest IBD Composite Ratings, which is a marker of strong stock growth. West was ranked #3 in the Health Care sector.

"We are honored that West has been recognized for our Corporate Responsibility initiatives by these two publications," shared Steve Walton, VP, HSE & Corporate Responsibility. "This recognition is a testament to the great work our team members are doing to make their communities and the world a better place. I’m excited to keep the momentum going as we push forward with a continued focus and commitment into 2020 and beyond."

In addition to this Top Companies recognition, over the past year West has received several additional CR focused awards, recognizing the global efforts of the Company and its team members. These awards include: the CSR Initiative Award and Corporate Social Responsibility Programme of the Year Award, both presented to West’s Dublin, Ireland site; the Goodwill Employer of the Year Award, presented to West’s Kearney, NE site; the West Chester University Corporate President’s Award; and the Philadelphia Business Journal’s Faces of Philanthropy distinction.

West’s award-winning Corporate Responsibility Program is committed to nurturing a culture of diversity and inclusion and supporting the communities in which its team members live and work. One major element of the Program is West’s culture of giving. West targets its global philanthropic efforts to support children, people with disabilities, healthcare and education, with a focus on STEM. Health and Safety is also a key focus area, as West is committed to designing and operating its facilities to provide a healthy and safe workplace. In addition, environmental considerations are taken into account for every aspect of West’s business, and its Sustainability Program targets reductions in areas where West can make the greatest difference: greenhouse gas emissions, waste, energy and water usage, and increased recycling.

Syros Announces First Patient Dosed in Phase 1 Clinical Trial of SY-5609, Its Highly Selective and Potent Oral CDK7 Inhibitor, in Patients with Select Solid Tumors

On January 28, 2020 Syros Pharmaceuticals (NASDAQ: SYRS), a leader in the development of medicines that control the expression of genes, reported that the first patient has been dosed in the Phase 1 clinical trial of SY-5609, its highly selective and potent oral cyclin-dependent kinase 7 (CDK7) inhibitor (Press release, Syros Pharmaceuticals, JAN 28, 2020, View Source [SID1234553620]). The trial is enrolling patients with advanced breast, colorectal, lung or ovarian cancer, or with solid tumors of any histology that harbor Rb pathway alterations.

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"SY-5609 represents a promising new approach for treating a number of cancers that have eluded treatment with other targeted approaches," said Kyriakos P. Papadopoulos, M.D., Co-Director of Clinical Research at South Texas Accelerated Research Therapeutics (START), and a clinical investigator in the trial. "We are always looking for opportunities to accelerate the development of new treatments to improve patients’ lives and give them real hope against cancer. SY-5609 has demonstrated compelling preclinical activity in a range of cancer models, and we are excited to further investigate it in this Phase 1 study."

SY-5609 has shown substantial anti-tumor activity, including complete regressions, in multiple preclinical models of solid tumors, including breast, colorectal, lung and ovarian cancers, at doses below the maximum tolerated dose (MTD). In preclinical studies of breast, lung and ovarian cancers, deeper and more sustained responses were associated with the presence of Rb pathway alterations. SY-5609 has also shown anti-tumor activity in combination with fulvestrant in treatment-resistant models of estrogen receptor-positive breast cancer, including those resistant to both fulvestrant and a CDK4/6 inhibitor.

"SY-5609 is a potentially transformative targeted approach for a range of difficult-to-treat cancers," said David A. Roth, M.D., Chief Medical Officer of Syros. "CDK7 inhibition attacks two fundamental processes in cancer: increased expression of cancer-driving genes, and uncontrolled cell cycle progression. Based on this dual mechanism and the exquisite selectivity and preclinical potency of SY-5609, we believe it could provide a profound benefit for patients in dire need of new therapies. We have designed our Phase 1 trial to move efficiently through dose escalation and to increase the chances of seeing early signals of clinical activity by focusing on patient populations we believe are most likely to respond."

The Phase 1 trial is a multi-center, open-label, dose-escalation trial that is expected to enroll approximately 60 patients with advanced breast, colorectal, lung or ovarian cancer, or with solid tumors of any histology that harbor Rb pathway alterations. The primary objectives of the dose escalation are to assess the safety and tolerability of escalating doses of SY-5609, with the goal of establishing an MTD. Additional objectives include assessments of anti-tumor activity, pharmacokinetics (PK), pharmacodynamics (PD) and potential predictive biomarkers, including Rb pathway alterations. In a future expansion portion of the Phase 1 trial, multiple cohorts are planned to further evaluate the safety and anti-tumor activity of SY-5609 as both a single agent and in combination with other therapies.

Syros expects to report initial safety, tolerability and PK/PD data in the fourth quarter of 2020 and additional dose-escalation data, including clinical activity, in mid-2021.