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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.

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]).

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.

"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.

Nymox Provides Update on Current Corporate Activities and Milestones

On January 28, 2020 Nymox Pharmaceutical Corporation (NASDAQ: NYMX) is reported to provide a current January 2020 update on several important corporate activities and achievements since the last update in October 2019 (Press release, Nymox, JAN 28, 2020, View Source [SID1234553619]).

The Company recently received the necessary information regarding the formatting and content of its upcoming regulatory filings for its Fexapotide Triflutate (FT) first in class injectable drug to treat the symptoms of prostate enlargement (BPH) in men. The Company is proceeding to integrate safety data from its four Phase I and Phase II BPH clinical trials as well as the safety data from Prostate Cancer Study NX03-0040 into the final dataset (that also includes 4 Phase 3 trials) that will be part of the New Drug Application (NDA) submission. The filings seeking approvals in the US and in Europe are now targeted for the first half of 2020 in both jurisdictions. At this point, the Company does not have any barriers to report and does not expect any delays.

Nymox is further pleased to report that another peer review publication (as anticipated in the Company’s October 21, 2019 Press Release) was recently accepted and published in Research and Reports in Urology. This publication discusses the selective cellular ablation capabilities of Fexapotide Triflutate to induce apoptosis (natural cell death) in prostate glandular cells which are a major part of the prostate enlargement which defines benign prostatic hyperplasia. Selective pharmaco-ablation is achieved while leaving the nerve cells and urethra and other nearby tissues (all crucial for normal sexual function) unaffected. In fact, the Company has previously reported a statistically significant improvement in sexual function reported by men treated with FT for BPH in its U.S. Phase III long-term follow up studies.

A fourth new and important peer review article is expected to appear in the near term. Further information will be provided when the new article appears.

Dr Paul Averback, CEO commented, "We are very pleased to provide these positive substantiated updates to shareholders today. Now, after many months of intensive work with our regulatory advisors and experts, we are confident that we have the needed clarity concerning the optimal formatting and content protocols being undertaken. The Company is currently highly focused on expeditiously completing the final legs of its regulatory pre-filing responsibilities."

The new peer review article reported in January 2020 and published in Research and Reports in Urology provided detailed documentation of the selective pharmco-ablation mechanism of action of FT, demonstrating the highly selective reduction of prostate cells which comprises one of the most important underlying reasons for the highly superior safety and efficacy of Fexapotide.

According to the new paper, "a traditional major challenge for treatment has been to promote or to directly produce tissue destruction that is structurally selective at the microscopic (histological) level, in order to avoid undesirable toxicities and irreparable damage to key adjacent structures. For example, transurethral resection, high energy laser extirpations and other methods may damage prostatic nerves and peri-urethral musculature, with the consequent occurrences of ejaculatory disorders, sexual dysfunction and /or incontinence."

The article further states, "this is the first demonstration of a molecular treatment that can produce structurally significant and focally targeted destruction of prostate epithelial gland growth combined with complete or near complete preservation of key nerves and structural elements in intimate structural proximity to the foci of ablation."

A review article on the progress in the development of Fexapotide entitled "Efficacy and safety of fexapotide triflutate in outpatient medical treatment of male lower urinary tract symptoms associated with benign prostatic hyperplasia" authored by Neal Shore, MD, FACS (Carolina Urologic Research Center, Myrtle Beach, SC); Ronald Tutrone, MD, FACS (Chesapeake Urology Research Associates, Baltimore, MD); and Claus G. Roehrborn, MD (University of Texas Southwestern Medical Center, Dallas, TX) was published in Therapeutic Advances in Urology. 2019;11:1-16.

The clinical trial results for Fexapotide treatment of BPH are published in the World Journal of Urology May 2018, Volume 36, pages 801–809 (View Source) in a peer review report entitled "Fexapotide Triflutate: Results of Long- Term Safety and Efficacy Trials of a Novel Injectable Therapy for Symptomatic Prostate Enlargement" authored by Neal Shore, MD, FACS (Carolina Urologic Research Center, Myrtle Beach, SC); Ronald Tutrone, MD, FACS (Chesapeake Urology Research Associates, Baltimore, MD); Mitchell Efros, MD, FACS (Accumed Research, Garden City, NY); Mohamed Bidair, MD (San Diego Clinical Trials, San Diego, CA); Barton Wachs, MD (Atlantic Urology Medical Group, Long Beach, CA); Susan Kalota, MD (Urological Associates of Southern Arizona, Tucson, AZ); Sheldon Freedman, MD, FACS (Freedman Urology, Las Vegas, NV); James Bailen, MD, FACS (First Urology, Louisville, KY); Richard Levin, MD, FACS (Chesapeake Urology Research Associates, Towson, MD); Stephen Richardson, MD (Jean Brown Research, Salt Lake City, UT); Jed Kaminetsky, MD, FACS (University Urology, New York, NY); Jeffrey Snyder, MD, FACS (Genitourinary Surgical Consultants, Denver, CO); Barry Shepard, MD, FACS (Urological Surgeons of Long Island, Garden City, NY); Kenneth Goldberg, MD, FACS (U T Southwestern Dept of Urology, Lewisville, TX); Alan Hay, MD, FACS (Willamette Urology, Salem, OR); Steven Gange, MD, FACS (Summit Urology Group, Salt Lake City, UT); Ivan Grunberger, MD, FACS (Brooklyn Urology, Brooklyn, NY).